Da Vinci Robotic Surgery System Gets Mixed Reviews In New FDA Report

The FDA released the results of an investigation into Intuitive Surgical’s da Vinci Surgical System in the wake of increased publicity "resulting from product recalls, media coverage, and litigation."

Intuitive has attracted scrutiny from regulators over the last two years. As Bloomberg put it this week, the company has faced "a rising number of reports about deaths, injuries, and malfunctions linked to" its robotic surgery system.

The company has undergone several recalls this year, according to FDA documents. For instance, the company recalled the patient side cart feature of the system this month due to "increased number of complaints regarding fluid entering the patient card base of the da Vinci S and SI systems."

The FDA probed surgeons' experiences with the system, releasing the findings late last week.

Surgeons may have little awareness about product recalls, the report suggested: "Of note, only three of the eleven respondents are aware of any recalls with the da Vinci Surgical System."

Surgeons reported some problems with patient outcomes, including "serums in obese patients (does not occur during laparoscopic surgery); and, limb palsy from arms being taped while in the Trendelenburg position," the FDA document said. 

The biggest challenges were "hand-eye coordination, use of the foot pedals, and learning the platform, (i.e., how to position the ports for instrument access to minimize collision of arms, and how to optimally place the arms to maximize positive surgical outcomes). The surgeons must rely on vision and judgment, since they are not directly touching the surgical instruments," the FDA report said.

But doctors also noted some positive impacts on patient outcomes, including less bleeding, less time in the hospital (only 24 hours in most cases), less pain and less pain medication needed, and an earlier return to work (five days post-op).

Certain hospitals were more diligent than others about ensuring surgeons learned how to use the system. "Some respondents have 'robotic' or credentialing committees in their hospitals with representation from one or more specialty areas to monitor training and practice," the report said.

The survey spoke with 11 surgeons from hospitals of various sizes who each performed 70 to 600 surgeries using the da Vinci Surgical System over the last three years. 

The Wall Street Journal explained the history of regulatory scrutiny into the company: "The FDA grew interested in Intuitive Surgical adverse events in 2011, leading to an inspection this year of the company and a warning letter from the agency," the WSJ article said. "The company said in a recent federal filing that it is correcting any violations that the FDA detected."